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Life Threatening? Yes
Write-up: Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor''s behalf. The subject was in the open-label phase of the study when the event occurred. A 17-year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug). The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life-threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self-administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021. The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure. Follow-up (27Jan2021 and 03Feb2021): Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE). Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine. Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine. Follow-up (11Mar2021): New information reported includes: SAE term updated to ''anaphylactoid reaction''. This is a final report for initial notification of a life threatening event. .; Sender''s Comments: The event ''anaphylactoid reaction'' is unlisted in the protocol''s Single Reference Safety Document (IB). Pfizer''s safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases. The information available in this report is very limited. The Company considers that there is a reasonable possibility that ''anaphylactoid reaction'' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past-history of anaphylaxis alone The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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